Mobile App for Multiple Myeloma

(THRIVE-M Trial)

Overseen By Hermioni Amonoo, MD, MPP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Acute psychiatric, Unstable cognitive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial aims to evaluate whether a psychosocial mobile application (THRIVE-M), is efficacious for improving quality of life, psychological distress, and fatigue in patients living with multiple myeloma compared to usual care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on evaluating a mobile app for improving quality of life, so it's likely you can continue your usual treatment.

What data supports the effectiveness of the treatment THRIVE-M for multiple myeloma?

The research suggests that digital health technologies, like mobile apps, can improve health outcomes for multiple myeloma patients by helping with medication adherence and monitoring patient-reported outcomes, which are important for managing the disease. ^{1 2 3 4 5}

How is the THRIVE-M treatment for multiple myeloma unique?

THRIVE-M is unique because it involves a mobile app designed to support patients with multiple myeloma by enhancing patient-centered care and improving health-related quality of life through digital health technologies, which is not a standard approach in current treatments. ^{3 5 6 7 8}

Research Team

Areej El-Jawahri, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults 18+ with multiple myeloma, whether newly diagnosed on first-line therapy, on maintenance therapy, or receiving their 2nd or 3rd line of treatment. Participants must understand and respond to English. Those with acute psychiatric conditions or unstable cognitive issues that prevent informed consent are excluded.

Inclusion Criteria

I am 18 or older with multiple myeloma and currently on maintenance therapy.

I am an adult with multiple myeloma undergoing my 2nd or 3rd treatment.

Ability to comprehend, read, and respond to questions in English

Exclusion Criteria

I am able to understand and follow the study's requirements.

Patients with acute or unstable psychiatric conditions that prohibit informed consent or compliance with study procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the THRIVE-M mobile application to improve quality of life, psychological distress, and fatigue

8 weeks

Questionnaires completed in person, over the computer, or by mail

Follow-up

Participants are monitored for safety and effectiveness after treatment using various scales and questionnaires

7 weeks

Treatment Details

Interventions

• THRIVE-M

Trial Overview The trial tests the THRIVE-M psychosocial mobile app's effectiveness in improving life quality, reducing psychological distress, and alleviating fatigue among multiple myeloma patients compared to those who receive usual care without the app.

Participant Groups

Group I: THRIVE-M Experimental Treatment 1 Intervention

Participants will be recruited from the Massachusetts General Hospital Cancer Center and randomized in a 1:1 fashion, stratified by diagnosis type (newly diagnosed versus maintenance versus relapsed), to THRIVE-M versus usual care. Participants will use THRIVE-M following a diagnosis of multiple myeloma to learn how to cope with physical symptoms, articulate their needs and navigate relationships, and focus on self-care while living with multiple myeloma using an iPad provided by the study team or the participant's own iPad. Questionnaires (in person, over the computer or telephone, or by mail) will be completed by participants at predetermined days per protocol days.

Group II: Usual Care Active Control 1 Intervention

Participants will be recruited from the Massachusetts General Hospital Cancer Center and randomized in a 1:1 fashion, stratified by diagnosis type (newly diagnosed versus maintenance versus relapsed), to THRIVE-M versus usual care. Questionnaires (in person, over the computer or telephone, or by mail) will be completed by participants at predetermined days per protocol days. Participants in the usual care arm will receive their usual care with the multiple myeloma team, including all routine supportive care resources (e.g., support from social work, psychology, or psychiatry) offered by the multiple myeloma team to all patients diagnosed with multiple myeloma. Patients in both the usual care and THRIVE-M group are permitted to use all supportive care services per usual care. We will track referrals to supportive care services in both groups by reviewing the Electronic Health Record (EHR).

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

Approximately 40% of multiple myeloma patients do not meet the criteria for phase 3 clinical trials, highlighting the need for treatment decisions that consider real-world factors like patient adherence, treatment feasibility, and quality of life.

Individual patient perspectives on treatment efficacy vary widely, necessitating a personalized approach to therapy that incorporates each patient's unique goals and experiences throughout their treatment journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of patients with multiple myeloma beyond the clinical-trial setting: understanding the balance between efficacy, safety and tolerability, and quality of life. Terpos, E., Mikhael, J., Hajek, R., et al.[2021]

The I-Can Manage program was developed through a user-centered co-design process involving 16 cancer patients and 19 clinicians, focusing on self-management of treatment toxicities with evidence-based content and features tailored to patient needs.

Usability testing showed high patient satisfaction with the program, indicated by a mean score of 3.75 on the Post-Study System Usability Questionnaire, suggesting it effectively supports patients in managing their cancer treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. Howell, D., Bryant Lukosius, D., Avery, J., et al.[2023]

The 'MM E-coach' is a newly developed e-health application designed to enhance patient-centered care for multiple myeloma patients, featuring modules for medication management, patient-reported outcomes, and communication with healthcare providers.

Initial usability testing showed a median score of 60 out of 100, indicating moderate usability, with positive feedback on its features from both patients and healthcare professionals, and a randomized clinical trial is underway to assess its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and development of an e-health application to deliver patient-centered care during treatment for recently diagnosed multiple myeloma patients: pilot study of the MM E-coach. Geerts, P., Eijsink, J., Moser, A., et al.[2023]

A study involving haematology specialists across three cancer networks in NHS Scotland identified 21 essential patient assessment skills for pharmacist independent prescribers who prescribe immunomodulators for myeloma patients.

The research highlights the collaborative role of pharmacist independent prescribers alongside consultants, suggesting that these skills could also be applicable for prescribing treatments for other blood cancers, aiding in the development of a competency framework for training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What patient assessment skills do pharmacist independent prescribers require to prescribe immunomodulators in myeloma? Slavin, A., Kurdi, A., Wilson, M.[2022]

Multiple myeloma (MM) patients experience significant health-related quality of life (HRQoL) challenges, particularly at diagnosis and relapse, highlighting the need for effective monitoring of their condition.

Digital health technologies, such as telemedicine and mobile health, have the potential to improve health outcomes for MM patients, but face barriers like limited access for older patients and a lack of integration with existing healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Health for Patients With Multiple Myeloma: An Unmet Need. Jagannath, S., Mikhael, J., Nadeem, O., et al.[2021]

In a study of 148 newly diagnosed multiple myeloma patients in Mexico, those treated in private healthcare systems had significantly better outcomes, with 65% achieving a very good partial response compared to 41% in public hospitals.

Patients in private care also had longer median progression-free survival (41 months vs. 23 months) and overall survival (79 months vs. 51 months), highlighting the impact of access to novel treatments and stem cell transplantation on survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the affordability of novel agents in patients with multiple myeloma: Real-world data of current clinical practice in Mexico. Tarín-Arzaga, L., Arredondo-Campos, D., Martínez-Pacheco, V., et al.[2019]

The Alexa skill Multiple Myeloma, launched in September 2019, provides patients with expert-reviewed information about multiple myeloma, including disease details, diagnostics, and therapy options, making it a valuable resource for patient education.

With 141 installations and 189 skill sessions analyzed, the skill effectively connects users to local patient support groups and offers interactive quizzes, although concerns about data protection and lack of need were barriers for some potential users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Convenient Access to Expert-Reviewed Health Information via an Alexa Voice Assistant Skill for Patients With Multiple Myeloma: Development Study. Baertsch, MA., Decker, S., Probst, L., et al.[2022]

A study involving 30 multiple myeloma patients showed that exercise therapy is safe and feasible, with no adverse events reported during the program.

Among those who adhered to the exercise regimen, significant improvements in physical functioning and a trend towards reduced fatigue were observed, suggesting that exercise may enhance quality of life for MM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical exercise therapy program with multiple myeloma patients: Impacts on feasibility, adherence and efficacy. Wefelnberg, MM., Niels, T., Holtick, U., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Management of patients with multiple myeloma beyond the clinical-trial setting: understanding the balance between efficacy, safety and tolerability, and quality of life. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Rationale and development of an e-health application to deliver patient-centered care during treatment for recently diagnosed multiple myeloma patients: pilot study of the MM E-coach. [2023]

4. England pubmed.ncbi.nlm.nih.gov

What patient assessment skills do pharmacist independent prescribers require to prescribe immunomodulators in myeloma? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Digital Health for Patients With Multiple Myeloma: An Unmet Need. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of the affordability of novel agents in patients with multiple myeloma: Real-world data of current clinical practice in Mexico. [2019]

7. Canada pubmed.ncbi.nlm.nih.gov

Convenient Access to Expert-Reviewed Health Information via an Alexa Voice Assistant Skill for Patients With Multiple Myeloma: Development Study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Clinical exercise therapy program with multiple myeloma patients: Impacts on feasibility, adherence and efficacy. [2023]